About this trial
This is a two-arm pilot randomized trial that assesses the feasibility and preliminary efficacy of a digital story and values clarification intervention (Considering alloHCT: Opportunities for Patient Reflection During Decision-Making via Digital Stories \[CHORDS\]) compared to usual care among patients with myeloid cancers considering allogeneic hematopoietic cell transplantation (alloHCT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >21 years old
Diagnosis of myeloid cancer (e.g. AML, MDS, myelofibrosis, CML, or MDS/MPN)
Being considered for alloHCT
Able to provide informed consent
Disqualifiers
Age >18 years old
Selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters."
Caregiver may be paid/professional or informal caregiver
Able to provide informed consent
Trial design
Parallel
Treatments tested in this trial
CHORDS
Other interventionThe CHORDS intervention consists of 1) digital stories created by individuals who previously underwent consultation for alloHCT and 2) explicit values clarification exercises designed to help patients reflect on their emotions and clarify what matters to them, including a) an interactive workbook, and b) best-worst scaling (BWS).
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Participants Retained (Feasibility - Retention Rate)
Feasibility will be assessed based on the percentage of enrolled participants who complete both the intervention and post-intervention secondary outcome assessments. The number of participants who complete all study procedures will be divided by the total number enrolled to calculate the retention rate. Higher percentages indicate greater feasibility.
Secondary outcomes
Mean Change in Decisional Engagement Scale Score
Engagement in decision making will be assessed using the Decisional Engagement Scale, a self-reported measure evaluating patient involvement and perceived shared decision making. A single score will be derived according to scale instructions. Higher scores indicate greater engagement in decision making. There are 10 items in the scale, with each items score ranging from 0 to 10 (range 0-100 for the entire scale).
Mean Change in Decisional Conflict Scale Score
Decisional conflict will be assessed using the Decisional Conflict Scale, a validated self-report instrument that measures personal uncertainty in making health-related decisions. The total score is derived by averaging item responses according to the scoring manual (range 0-100). Higher scores indicate greater decisional conflict (worse outcome), while lower scores indicate less conflict (improvement).
Mean Change in Distress Thermometer Score
Psychological distress will be measured using the NCCN Distress Thermometer, a single-item visual analog scale ranging from 0 ("no distress") to 10 ("extreme distress"). Higher scores indicate greater distress.
Other outcomes
Qualitative Analysis of Patient-Hematologist Discussion of Values and Goals
Audio recordings of alloHCT office visits will be transcribed and analyzed using qualitative methods to identify the presence and nature of discussions related to patient values and treatment goals.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.